One year has now passed since the ‘new’ EU IVD and medical devices regulations entered into force.
Since Day 1, the medical technology industry has been working at full capacity to achieve and maintain maximum possible readiness. While I’d love to claim the same for all other essential elements of the new regulatory system, progress has so far been too slow and piecemeal.
Let me repeat that: To the fullest extent possible, industry is ready, but the system is not.
Time is running, and it’s running fast. Unless all essential elements of the new system are in place soon, time could very well run out.
It could run out for our industry, for sure, but also for the hospitals, laboratories, patients and physicians who rely, every day, on life-saving and life-transforming medical technology products.
Why, you ask? Surely the new EU regulations were designed to increase patient safety, better protect public health, and ensure both legal certainty and an innovation-friendly environment, right?
Yes, those are the goals, but as we have been saying from the very beginning, these benefits can only be achieved if the necessary building blocks of the new regulatory system are in place early-on.
Well, one-third of the transition period is now gone for medical devices. There is a little more time for IVDs, but on that front the work is even more daunting.
Time running out to put the system in place
Our regulators have been working as fast as they can, despite systemic resource constraints, it’s true that a few pieces of the system have started to emerge in the past 12 months.
However, a huge amount is still outstanding, and is needed for manufacturers to fully comply by the dates of application.
For instance, to date, we still have none of the following:
– The new Eudamed database (though intense preparations are underway)
– The vast majority of needed Delegated and Implementing Acts (we have 1, but according to the European Commission, we need at least 17 more)
– Expert panels and reference laboratories (none so far)
– Harmonized standards (nada)
– Common specifications (zip), and above all
– Notified Bodies!
Phew! That’s quite an imposing To-Do list given the time remaining, especially for a sector whose competent authorities are in many instances still staffing up to meet their many new obligations.
If all those above-listed elements are in place by the Regulations’ dates of application, then implementation may look on-track, at least on paper.
The reality, however, is that we need these things well before the dates of application. Delegated and Implementing Acts need to be read, understood and implemented like all other laws. Ditto for common specifications. Until expert panels and reference laboratories are up-and-running, certain high-risk devices cannot be CE marked.
And so on…
Notified Body capacity is key
The most important element of all, however, is the Notified Bodies.
Industry is growing more nervous every day, as it seems increasingly likely that we will have too few Notified Bodies, available too late, covering too few product categories, and (above all) with far too little capacity.
To date, no Notified Body has been designated under either Regulation, and we hear that out of the 20-30 applications for designation submitted since November 2017, we hear that only two on-site assessments have taken place so far.
Make no mistake: Unless authorities can ensurethe early availability and capacity of Notified Bodies, we could see a drastic impact on the health market that no-one wants to see.
I’m not referring to delays in product innovation, though that’s a risk too.
No, what I’m referring to is the systematic, en masse discontinuation of a great many existing medical technology products that the healthcare system has known, used and depended upon for many years.
This should come as no surprise. The vast majority of IVDs and medical devices cannot be transitioned to the new rules without a Notified Body. So, unless Notified Bodies are available to all, well before the dates of application, manufacturers will naturally devote the time they still have to getting their most high-priority products certified to the new Regulations. In the face of uncertainty about how to transition their products, those devices that are not essential to a manufacturer’s own survival, risk being retired.
To be fair, the co-legislator tried to avoid this very situation, by allowing manufacturers to renew their existing Notified Body certificates up until the dates of application. On paper, this mechanism seems to enable industry to keep various existing products available for a few more years after the dates of application, before bringing them into full conformity with the new Regulations.
It was a good idea, but it is unfortunately suffers from one key problem: very simply, the Notified Bodies still need the in-house capacity to renew thousands of existing certificates. In the case of medical devices they need to get all those renewals done in the next 1-2 years, and work is work, regardless of whether it is done in the context of the new Regulations or the previous Directives.
Given that our remaining 59 Notified Bodies are already struggling to stay on top of their existing workloads, they simply do not have the capacity to process the massive bubble of certificate renewals that would need to be done.
So again, manufacturers will naturally give priority to those certificates that they most need to see renewed, leaving others to be renewed only if there is enough time and capacity in the system. If either element is lacking, the products could regrettably disappear.
Putting the healthcare system at risk
Everyone in industry knows and understands all this. A great many competent authorities, including the European Commission, seem to understand this too. However, when we speak to patients, healthcare professionals, hospitals and laboratories, it’s clear that no-one proactively informed them that so many products they know, use and need, might no longer be available in Europe.
Well, it’s time they knew: we are all fast approaching the point of no return. Call it what you will: a cliff-edge scenario, a supply chain disruption, or an outright market failure.
Whatever you call it, one thing is clear: the IVDR/MDR transition periods were constructed such that the clock started ticking on Day #1, and everyone started implementing immediately, hoping against hope that everything would fall into place on time.
For some scenarios – like if the new Eudamed database is delayed – there are back-ups plans that kick in and allow the new system to continue functioning.
It’s a real shame that similar safety nets don’t exist for Notified Bodies and other essential elements. The co-legislator simply hoped that we would all have enough time, but put no Plan B into the legal text that it could activate in case time runs out.
Well, time is running fast, and the ticking clock has no way to either stop or slow down. Unless our regulators can reassure us all that Plan A is sure to work, or that there is a concrete, feasible plan – to cover all devices for which Notified Bodies are not available – industry nervousness will get worse.
It’s time to talk about time…not just in blogs and in private meetings, but in public.
Solutions need to be planned-out and communicated to all affected stakeholders.
The risks of doing otherwise out are simply too high.